I apologize for a delayed response. I have not had yet a chance to review my inspection notes; nevertheless, the list that you provided appears to cover most of the issues that still need to be looked at. We will let you know if we need anything else.

One thing that I do remember that is not included is safety information for the in-line filter needle. I think you planned to ask the manufacturer to send the information directly to us. Additional question that I have is about -(b)(4)---------------------------------------------. Does -----------(b)(4)-----------------------------------------------------------------? If not, we will need information on extractables/leachables.

Please consolidate the response as much as possible, e.g., please provide items 1, 2, and 3 in one amendment.

We would appreciate your input on the content of the upcoming amendment(s) we intend to submit as soon as possible covering the outstanding subjects discussed during the inspection as listed below. We would like to send you the information as soon as it is available, thus the above information might be submitted in more than one submission.